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FDA 510(k) Application Details - K052863
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K052863
Device Name
Ventilator, Continuous, Facility Use
Applicant
HAMILTON MEDICAL AG
VIA NOVA
RHAEZUENS CH-7403 CH
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Contact
CURDIN DANUSER
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
CBK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/2005
Decision Date
01/06/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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